Nipple surgery may be performed on patients as a result of cancer treatment, trauma, or congenital abnormalities (such as an inverted nipple). Following a mastectomy procedure to treat breast cancer, nipple reconstruction surgery is most often done as the final stage of the breast reconstruction process.
Nipple reconstruction greatly increases the achievement of a realistic looking breast, and provides tangible psychological benefits to patients undergoing breast reconstruction. Nipple size, projection, position, shape, and color are key considerations in the reconstruction process. However, the achievement of a lasting aesthetic result can be an elusive goal.
Contemporarily, nipples are generally reconstructed from incised local flaps of skin and fat that are elevated from the breast mound to create a protrusion. The incised donor sites on the breast mound are typically closed by suturing the opposing skin edges together. Popular local skin flap procedures include the Skate Flap, S-Flap, and Star Flap.
Local skin flap procedures have generally replaced the use of (non-local) tissue grafts for nipple reconstruction. Tissue graft techniques that use tissue taken from the vaginal area or the ear lobe to construct the new nipple are no longer in favor due to the difficulty in preserving the blood supply to the transplanted tissue; which if compromised can lead to the death of the transplanted tissue.
Regardless of the specific nipple reconstruction technique that is used, size, projection, position, shape, and color are key considerations.
The post surgical recovery process for a newly constructed, or reconstructed nipple mirrors that of the wound healing process and is comprised of multiple stages that last several months to a couple of years. Table 1 provides a summary or overview of the entire wound (and reconstructed nipple) healing process.
TABLE 1StageCharacteristicsLengthOneThis stage often goes by the name ofLasts several days:homeostasis and/or inflammatory phase.immediately after theClotting occurs and blood vessels arewound is createdconstricted to control bleeding in theto 2-5wound. Inflammation occurs and is adays total.visible indicator of the immune response.White blood cells clean the area of debrisand bacteria.TwoKnown as the metabolic or proliferativeBegins after stage onephase. The body produces collagen to filland lasts about 3voids and to strengthen the wound.weeks.Stronger and thicker scars, than areultimately needed, are produced. Newblood vessels form. Wound edges pulltogether and moist areas are covered by alayer of skin.ThreeGenerally goes by the name of maturationBegins after stage twoor remodeling phase. During this stage,and lasts up to 2 years.the body refashions the scar and decideshow much will remain. New collagenforms, which changes the shape of thewound and increases the tensile strength oftissue in the area.
Immediately following surgery, the reconstructed nipple is typically larger in size and has a more pronounced projection than it will ultimately have. This is mostly due to localized inflammation, the fact that the tissue has not yet tightened and scarred down, and the absence of compression forces on the nipple immediately following the surgical procedure.
One of ordinary skill in the art will recognize, upon reading this description, that the use of a local skin flap procedure, to create a new nipple, produces a larger contiguous wound that is comprised of the newly constructed nipple and the connected, sutured local donor skin site. In contrast, for tissue graft procedures, the tissue graft donor site area (e.g., typically the vaginal area or ear lobe) is distinct from the nipple site. For tissue graft procedures, the two wound sites heal independently of each another.
Despite a surgeon's technique and expertise with a particular local skin flap procedure, the created nipple will experience shrinkage and may even completely flatten. External compression forces on the nipple, such as from wearing a bra, and tensile, or pulling forces from scar tissue that forms within the local donor site area conspire to flatten the constructed nipple. It is common for the ultimate result to be a very small protrusion or no protrusion at all. One of ordinary skill in the art will readily observe that an effective treatment for nipple flattening must counteract the pulling forces on the newly created nipple that originate in the local skin flap donor site area and are characteristic of Stage Two and Stage Three of the healing process. Consequently, for local skin flap procedures the scope of an effective therapy to counter nipple flattening must cover Stage Two and Stage Three of the wound healing process summarized in Table 1.
Immediately following surgery, the common practice is for the nipple to be covered with antibiotic soaked gauze, and then is dressed with additional gauze that is cut in a donut shape and placed around it. The donut gauze is layered to the height of the nipple in an attempt to maintain the size, shape, and projection of the nipple. The distal tip of the nipple and surrounding gauze are then covered with more gauze and secured with either medical tape and/or a plastic waterproof cover. Some surgeons additionally cut off the end of a syringe and use it with layers of gauze to protect the nipple against external forces during the initial healing phase (i.e., Stage One of Table 1).
The post operative dressing remains on the patient for about three to five days, until the patient's follow-up, at which time the nipple is redressed in the same fashion except for the antibiotic soaked dressing. The patient is then instructed to change the dressing after showering for the following one to two weeks. During this phase of the recovery and healing time, the patient is typically instructed to not wear a compressive bra and to not undertake any activities where the stitches and integrity of the nipple could be compromised. Of course, specific protocols in regards to surgical procedure, dressing, and post-op care and instructions may vary with individual surgeons' technique and preferences.
One of ordinary skill in the art will recognize, upon reading this description, that while the use of layers of gauze and the use of prior art purpose-built surgical bandages, e.g., as described by Imonti in U.S. Pat. No. 4,754,750 and U.S. Pat. No. 4,870,977 (hereinafter “Imonti”), may be appropriate to protect a newly constructed nipple during Stage One and the very beginning of Stage Two of the healing process (see Table 1), these approaches do not adequately address the latter part of Stage Two and Stage Three of the healing process for nipples constructed using local skin flap procedures, wherein the action of the scar tissue within the donor site area pulls and flattens the nipple.
Neither the use of layers of gauze nor the use of the device described by Imonti does anything to counteract the pulling forces on the newly created nipple that originate in the local skin flap donor site area.
The surgical bandage defined in Imonti predates today's local skin flap procedures and full to anticipate the contribution of the pulling forces within the donor site area to nipple flattening. The Imonti surgical bandage is optimized for Stage One of the healing process for a newly constructed nipple and explicitly references nipples that are created from tissue grafts. For example, Imonti '977 states, at column 1, line 14, “Tissue is taken from the vaginal area or ear lobe to construct the nipple . . . ”; and at column 1, line 62, “A further object of the present invention is to provide an improved bandage for the areola and nipple area which bandage is carefully configured so as to minimize contact with the reconstructed tissue of that area . . . ” In describing the surgical bandage, Imonti confirms, at column 2, line 28 “A preferred design of the protector member has a generally flat upper surface. A large medication opening passes through the center of that surface is surrounded by a raised annular rim having a plurality of spaced suture holes through it. The raised wound, such as a reconstructed nipple, in the protector member can then be sutured through the suture holes so that it can stand up in the protector member without slumping down . . . ” Further, column 4, line 59 of Imonti '977 again explicitly cites nipples that are constructed via a tissue graft procedure: “The newly-constructed nipple often tends to lean or sag during the healing process and so the present invention provides for circumferentially and radially spaced suture holes 64 in protector member 14′.” One of ordinary skill in the art will recognize, upon reading this description, that the process of nipple sagging which is characteristic of tissue graft nipple reconstruction procedures is distinct from the process of nipple flattening which is characteristic of local skin flap procedures.
A principal objective of the nipple reconstruction guard according to embodiments of the present invention is to overcome the limitations of prior art bandages by specifically counteracting the pulling forces on the newly created nipple that originate in the local skin flap donor site area during Stage Two and Stage Three of the healing process for a newly created nipple.